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NCT01902394 · ClinicalTrials.gov registry record · NA

The Addition of Whole Grains to the Diets of Adults: A Study of Digestive Health and Natural Defenses

A NA study of Digestive Health and Immune Function, sponsored by Tufts University.

Completed
Registry status
NA
Development phase
108
Enrollment target
1
Study location

NCT01902394: Completed NA study of Digestive Health and Immune Function, sponsored by Tufts University.

NCT01902394 is a NA study of Digestive Health and Immune Function that has completed, run by Tufts University. The registered enrollment target is 108 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01902394, a NA study of Digestive Health and Immune Function, has completed, sponsored by Tufts University.

COMPLETED
Registry status
NA
Development phase
108 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to determine if substituting whole grains for refined grains in the diets of healthy adults over a period of 6 weeks alters the composition of the bacteria in the gut, and has beneficial effects on immune function, digestive health, cardiovascular health, regulation of body weight and composition, and vitamin K status. The investigators hypothesize that whole grain consumption over a period of 6 weeks will alter the gut microflora toward a more beneficial bacterial profile, improve the immune response while reducing oxidative stress and inflammatory markers, have favorable effects on factors influencing the regulation of body weight and composition,increase bacterial vitamin K synthesis, and beneficially effect surrogate markers of cholesterol synthesis/absorption, vitamin D concentrations, and whole genome DNA methylation patterns. In statin users it is hypothesized that, consumption of whole grains will alter statin pharmacokinetics by decreasing rate of statin absorption, resulting in more sustained plasma concentrations.

Primary Outcome

Delayed-type hypersensitivity (DTH) and lymphocyte proliferation will be measured at baseline (week 2 of washout period) and at week-6 of the diet intervention to assess adaptive immune function, specifically T cell-mediated immunity.

Interventions

  • OTHER Whole grains
  • OTHER Refined grains

Study Locations (1)

Massachusetts

  • HNCRA at Tufts University - Boston

Trial Details

FieldValue
Enrollment Target 108 participants
Start Date 2012-06
Est. Completion 2014-09
Phase NA
Tufts University

163 total trials

What the finished NCT01902394 record still lists

NCT01902394 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).

The record links to 1 condition, with Digestive Health and Immune Function appearing as the primary indexed condition, and to 2 interventions - of which Whole grains is the first listed.

NCT01902394 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT01902394 about?

NCT01902394 is a clinical study titled "The Addition of Whole Grains to the Diets of Adults: A Study of Digestive Health and Natural Defenses". The purpose of this study is to determine if substituting whole grains for refined grains in the diets of healthy adults over a period of 6 weeks alters the composition of the bacteria in the gut, and has beneficial effects on immune function, digestive health, cardiovascular health, regulation of b...

What is the current status of trial NCT01902394?

This trial is currently completed. It is a NA study. The enrollment target is 108 participants. The study started on 2012-06. Estimated completion is 2014-09.

What conditions does trial NCT01902394 study?

This clinical trial studies the following conditions: Digestive Health and Immune Function.

What interventions are being tested in trial NCT01902394?

The interventions under investigation include: Whole grains (OTHER), Refined grains (OTHER).

Who is sponsoring clinical trial NCT01902394?

This trial is sponsored by Tufts University, which has 163 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01902394 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT01902394's enrollment target sits among peer trials

108 825th of 2000 higher than 1,171 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01902394, the US trial registry maintained by the National Library of Medicine. NCT01902394 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.